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Biologic Drug

A complex medication derived from living cells — including monoclonal antibodies, vaccines, and cell therapies — that treats serious conditions like cancer and autoimmune diseases.

How It Works

Biologics are fundamentally different from traditional small-molecule drugs. They're produced inside living organisms (bacteria, yeast, mammalian cells) and consist of large, complex proteins that cannot be exactly replicated. This complexity is why biologics are expensive: manufacturing requires specialized facilities, cold-chain storage, and extensive quality control. Biologics include blockbuster drugs like Humira (adalimumab), Keytruda (pembrolizumab), and Stelara (ustekinumab). Because they can't be exactly copied, the generic equivalent of a biologic is called a "biosimilar" rather than a generic, and the approval pathway requires more extensive testing.

Related Terms

  • BiosimilarA biologic product that is "highly similar" to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
  • Specialty DrugA high-cost medication — typically above $1,000 per month — that treats complex or chronic conditions and often requires special handling, storage, or administration.

About This Definition

This definition is part of the DrugPrice Drug Pricing Glossary34 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.